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Clinical Study on Endoscopic Management of GOV1 Esophagogastric Varices

Clinical Study on Endoscopic Management of GOV1 Esophagogastric Varices Based on CT Hemodynamics

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05978752
Enrollment
57
Registered
2023-08-07
Start date
2023-12-31
Completion date
2025-11-30
Last updated
2023-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal and Gastric Varices

Keywords

GOV1 esophagogastric varices, HVPG, endoscopic treatment

Brief summary

The patients with GOV1 esophagogastric varices will be treated with gastric variceal tissue gel injection, at the same time, the esophageal varices were treated with ligation, sclerotherapy, or no treatment. A new method for the treatment of esophageal varices will be proposed to improve the effective rate and reduce the recurrence rates and mortality, shorter hospital stays, and lower treatment costs, while further expanding HVPG testing to develop the best strategy for secondary prevention of endoscopic treatment in patients with GOV1 type esophageal and gastric varices.

Detailed description

Cirrhotic portal hypertension can cause esophageal and gastric varices, and esophageal and gastric varices bleeding (EGVB) were associated with portal vein pressure. At present, the gold standard for detecting portal pressure in clinical practice is hepatic venous pressure gradient (HVPG). For Sarin classification GOV1 of esophagogastric varices are from a single origin, the left gastric vein. If the fundus varicose veins receive complete embolization treatment, the esophageal variceal blood flow should be completely blocked, and such patients do not need to perform esophageal surgery. However, this has not been reported in the literature. Patients with esophageal and gastric varices identified by CT as GOV1 will be enrolled, all of whom will receive HVPG detects. The patients were randomly divided into three groups. The patients in group A will receive endoscopic gel embolization for gastric varices and esophageal varices ligation treatment, group B patients will receive endoscopic gastric variceal tissue glue embolization and esophageal variceal sclerotherapy treatment, the patients in group C will receive endoscopic gelatinization of gastric fundus varices (esophageal varices were not treated). Patients in the three groups were followed up with CTP and gastroscopy 1 month, 3 months, and 6 months after the initial treatment, and additional endoscopic treatment will be provided if necessary. If bleeding occurs again during this period, timely treatment (medication, endoscopy, intervention or surgery) is required according to the condition. A new method for the treatment of esophageal varices will be proposed to improve the effective rate and reduce the recurrence rates and mortality, shorter hospital stays, and lower treatment costs, while further expanding HVPG testing to develop the best strategy for secondary prevention of endoscopic treatment in patients with GOV1 type esophageal and gastric varices.

Interventions

PROCEDUREEndoscopic gel embolization of gastric fundus varices and ligation of esophageal varices

For patients with GOV1 esophagogastric varices, gastric varices will be treated with endoscopic gelatinous embolization, esophageal varices will be treated with ligation.

PROCEDUREEndoscopic gel embolization of gastric fundus varices and sclerotherapy of esophageal varices

For patients with GOV1 esophagogastric varices, gastric varices will be treated with endoscopic gelatinous embolization, esophageal varices will be treated with sclerotherapy.

PROCEDUREEndoscopic gelatinous embolization of gastric varices (esophageal varices not treated)

For patients with GOV1 esophagogastric varices, only gastric varices will be treated with endoscopic gelatinous embolization, esophageal varices will not be treated.

Sponsors

Jinhua Hospital Affiliated to Zhejiang University
CollaboratorUNKNOWN
Lanxi People's Hospital
CollaboratorOTHER
Lishui Country People's Hospital
CollaboratorOTHER
Shandong Provincial Hospital
CollaboratorOTHER_GOV
Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Intervention model description

The patients with GOV1 esophagogastric varices were treated with gastric variceal tissue gel injection, at the same time, the esophageal varices were treated with ligation, sclerotherapy, or no treatment. A new method for the treatment of esophageal varices was proposed to improve the effective rate and reduce the recurrence rates and mortality, shorter hospital stays, and lower treatment costs, while further expanding the value of HVPG testing.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* GOV1 esophageal and gastric varices identified by CT; more than 18 years old;

Exclusion criteria

* Complicated with liver cancer, severe cardiopulmonary insufficiency, stage III and above hepatic encephalopathy, severe natural portal shunt formation, and previous treatment of portal hypertensive bleeding (including endoscopic, interventional, and surgical procedures).

Design outcomes

Primary

MeasureTime frameDescription
hemostasis rate6 monththe percentage of hemostasis

Secondary

MeasureTime frameDescription
Postoperative bleeding recurrence rate6 monthRebleeding rate after endoscopic treatment: including hematemesis and/or black stool, hemoglobin decrease \>10g/L

Contacts

Primary ContactHongxia Li, Doctor
lhx100918@163.com+8618252006898
Backup ContactWei Wei, Master
wwze@zju.edu.cn+8615267175186

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026